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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K112728
Device Name HEPAIRX VENTILATING AIR PURIFIER
Applicant
Air Innovations, Inc.
7000 Perforance Dr.
North Syracuse,  NY  13212
Applicant Contact LAWRENCE WETZEL
Correspondent
Air Innovations, Inc.
7000 Perforance Dr.
North Syracuse,  NY  13212
Correspondent Contact LAWRENCE WETZEL
Regulation Number880.5045
Classification Product Code
FRF  
Date Received09/20/2011
Decision Date 01/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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